Home NDC 69729-786 Tesalon Children
Product NDC 69729-786
11-digit product format 697290786
Labeler code 69729
Product ID 69729-786_2309620a-ccbd-41e9-e063-6394a90a9520
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Guafeisin USP, Phenylephrine HCl
Dosage form SYRUP
Route ORAL
Labeler OPMX LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-27
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength 200; 13.33; 5; 250 mg/10mL; mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tesalon Children
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 200 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 13.33 mg/10mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL ACETAMINOPHEN 250 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1790651 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69729-786-06 Tesalon Children 1 in 1 CARTON SYRUP 1 1 69729-786-06 Tesalon Children 177 mL in 1 BOTTLE, PLASTIC SYRUP 177 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69729-786 TESALON CHILDREN (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCL) SYRUP [OPMX LLC] 1 Current NDC, 2 package rows 20240929_2309620a-ccbc-41e9-e063-6394a90a9520.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69729-786-06 69729078606 1 BOTTLE, PLASTIC in 1 CARTON (69729-786-06) / 177 mL in 1 BOTTLE, PLASTIC 2024-09-27 No No Current